Main Subject - Business

Do you ever feel like your mind is a million miles away? You can watch someone in a meeting who is “somewhere else,” and they have a far-away, glassy look to the eye. You know they are not hearing a word of what is being said. They may be with you physic

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ally, but their minds are somewhere else, thinking about some meeting, worrying about that errand, or trying to figure out what someone meant by a passing comment.

Contrast that with a time you were so immersed in an activity that time just stood still?

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

Your stomach suddenly growls, and you look up at the clock to discover you worked right over your lunch hour and didn’t notice! You were totally immersed in what you were experiencing or doing. What are the benefits of this extreme focus?

• Output is i

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

creased. You simply get more done when you are 100% attuned to your task. You’ll get more letters written and more projects completed

• You perform optimally and do your best work. If you are giving your total attention to something, the quality will be

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

better. Isaac Newton said, “If I have ever made any valuable discoveries, it has been owing more to patient attention than to any other talent.”

• The time invested in projects is decreased. If you don’t feel like doing something in the first place (lik

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

paying bills), wouldn’t you rather have it over in an hour instead of stretching it out over three?

• Less rework. Your focus reduces the time it would have taken you to correct the mistakes and omissions that are a byproduct of inattention.

• Peace of

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

mind is enhanced. There is an old legend about a man who travels the world searching for the meaning of life. One day he climbs a high mountain to a monastery to get the advice of a monk who is reputed to be the wisest man on earth. When asked for the s

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ecret to happiness, the monk replies simply, “DO whatever you’re doing.”

What are some of the characteristics of the non-flow state?

?? Continually stopping one task and starting another

?? Not establishing a goal or “end” state

?? Constant disruptions

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

and interruptions, which make it difficult to concentrate

?? Feeling overwhelmed

?? Low energy period

What are some characteristics of the flow state?

?? A vested interest in the outcome

?? A strong belief that you can and will accomplish your goal

??

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

Total focus, with no interruptions

?? High energy period

?? Passion/fun/enjoyment

?? Proper environmental conditions (temperature, smells, noise)

?? Minimal effort required (low learning curve)

How do you achieve this wonderful state of flow and becom

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

fully present-focused?

• Master your job. Research shows that your ability to experience flow is related to your mastery of the mechanics of your job. The more unfamiliar you are with your work, the harder it is to achieve. Just as learning to drive w

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

as at first a conscious behavior, when mastered, it became subconscious. If you’re on a learning curve in a new activity, it will be harder to achieve intense focus. The more you learn the job, the better your ability to concentrate and “let go.”

• Prep

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

are for and expect to achieve focus. Set your mind properly. Consciously, willfully decide that you are going to concentrate. Have a positive attitude going into the task. Prepare your materials in advance of getting started and have what you need at you

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

fingertips.

• Clear your desk. Do your piles talk to you? “Do me!” “Don’t forget me!” Clutter can be psychologically distracting. You will focus better on what’s in front of you if you don’t have ten other things surrounding you. Clear the piles, so ev

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

erything is out of your line of sight except the single thing you’re working on.

• Set aside some time. Estimate how long the task will take and schedule an appointment with yourself on your calendar. Total absorption is very relaxing. It’s splitting yo

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ur attention—between what you’re currently doing and what you have to do next—that’s exhausting. When you become focused on the task of the moment, time seems to fly, and you get the job done easier and faster.

• Ensure no interruptions. The ability to

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ork uninterrupted is very important to devote your complete attention to an activity. Having privacy will help you achieve a state of flow. Tom DeMarco and Timothy Lister, co-authors of Peopleware: Productive Projects and Teams, claim reaching a state o

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

f flow requires at least 15 minutes of ramp-up concentration. People are especially sensitive to interruptions during this time. When people are disrupted, they can’t go right back in. They require an additional 15 minutes of time to get started again. T

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

is leads to increased frustration and reduced productivity. Close your door if you have one, or leave your office and retreat to an empty office where no one can find you.

Take each step deliberately and with full attention. Strive to be “in the moment.

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

” When you read a book to your child, really READ a book to your child. Don’t be focused on all the to-dos that you must do when you’re finished. Be present and available and in the now for those people and tasks you care about.

Make it a productive day

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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A lack of presentation training in America is creating a business culture that abuses presentation software and the art of public speaking. Let's get back to the basics and adopt something I like to call the BRAVO formula.

Brainstorming is a well tested method for generating ideas. Originally intended for groups, brainstorming can also be practiced alone. Read about how you can use brainstorming to solve problems.

It's not just commercials on television and radio that need actors to read information off-camera. There are a myriad of ways to use voice to educate, inform, guide, entertain, and, of course, sell. ...

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